BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3242478 · Received July 23, 2013

    Report

    Report Number
    2531779-2013-11694
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    June 30, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 09/24/2013 WITH THE FOLLOWING FINDINGS: DURING EVALUATION, THERE WAS MOISTURE BEHIND DISPLAY LENS. THE PUMP POWERED ON WITH AN AUDIBLE TONE, VIBRATION AND A BLANK DISPLAY. A REVIEW OF THE PUMP HISTORY SHOWED ONE REPLACE BATTERY ALARM ON 06/30/2013. THERE WAS NO EVIDENCE OF EXCESSIVE BATTERY USAGE OBSERVED IN BLACK BOX. A VISUAL INSPECTION OF THE BATTERY COMPARTMENT SHOWED IT TO BE INTACT. THERE WAS NO EVIDENCE OF MOISTURE CONTAMINATION INSIDE BATTERY COMPARTMENT. THE BATTERY CAP WAS ABLE TO FULLY TIGHTEN TO THE PUMP. A POWER LOSS WAS NOT OBSERVED. EVALUATION REVEALED THE PUMP CASE WAS CRACKED IN UPPER RIGHT HAND CORNER OF THE DISPLAY AREA. A LEAK TEST SHOWS LEAK AT CRACK IN PUMP CASE. THE PUMP CASE WAS REMOVED AND EVIDENCE OF MOISTURE CONTAMINATION WAS FOUND INSIDE PUMP, ON MOTOR FLEX CABLE AND CONNECTOR AS WELL AS ON DISPLAY FLEX CABLE AND CONNECTOR. ADDITIONAL TESTING WAS NOT ABLE TO BE PERFORMED DUE TO THE BLANK DISPLAY AND INTERNAL MOISTURE DAMAGE. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS, ALLEGING A POWER (BATTERY LIFE W/ MOISTURE) ISSUE; VISIBLE MOISTURE BEHIND THE DISPLAY SCREEN WITH SHORT BATTERY LIFE. THIS COMPLAINT IS BEING REPORTED BECAUSE THE REPORTED ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WAS NO INDICATION THAT THE PRODUCT CAUSED OR CONTRIBUTED TO AN ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343725 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR